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FDA 510(k)

BIO-CONSOLE, MODEL 560

K-Number: K070286 · 2007-05-22

ApplicantMedtronic
Decision Date2007-05-22
Product CodeDWA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BIO-CONSOLE, MODEL 560 is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic. It received FDA 510(k) clearance on 2007-05-22 under 510(k) number K070286. The device is classified under product code DWA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO-CONSOLE, MODEL 560?

BIO-CONSOLE, MODEL 560 is a medical device that received FDA 510(k) clearance on 2007-05-22. The listed applicant is Medtronic. The 510(k) number is K070286.

When did BIO-CONSOLE, MODEL 560 receive FDA 510(k) clearance?

BIO-CONSOLE, MODEL 560 received FDA 510(k) clearance on 2007-05-22, under 510(k) number K070286.

Who is the listed applicant for BIO-CONSOLE, MODEL 560?

The FDA 510(k) record lists Medtronic as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIO-CONSOLE, MODEL 560?

The FDA product code for BIO-CONSOLE, MODEL 560 is DWA.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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